Ensuring balance in national policies on controlled substances
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Ensuring balance in national
policies on controlled substances
GUIDANCE FOR AVAILABILITY AND ACCESSIBILITY
OF CONTROLLED MEDICINES
Access to Controlled Medications
Programme
Department of Essential Medicines ISBN 978 92 4 156417 5
and Pharmaceutical Policies
World Health Organization
20 avenue Appia
CH-1211 Geneva 27
Flash-OMS-EMPP-RapportWillem-EN-Couv-20110329.indd 1 29/03/11 16:33
A c c e s s t o C o n t r o l l e d M e d i c a t i o n s P r o g r amm e
Ensuring balance in national
policies on controlled substances
Guidance for availability and accessibility
of controlled medicines
WHO Library Cataloguing-in-Publication Data
Ensuring balance in national policies on controlled substances: guidance for availability and accessibility of controlled
medicines.
Revised edition of “Narcotic and psychotropic drugs: achieving balance in national opioids control policy: guidelines for
assessment”, World Health Organization, Geneva, 2000 (WHO/EDM/QSM/2000.4).
1.Drug and narcotic control. 2.Essential drugs - supply and distribution. 3.Health policy. 4.Human rights. 5.Legislation,
medical. 6.Legislation, pharmacy. 7.Opioid related disorders - prevention and control. 8.Guidelines. I.World Health
Organization.
ISBN 978 92 4 156417 5 (NLM classification: QV 33.1)
© World Health Organization 2011
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e-mail: permissions@who.int).
The designations employed and the presentation of the material in this publication do not imply the expression of
any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country,
territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines
on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or
recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained
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event shall the World Health Organization be liable for damages arising from its use.
Design and Layout: paprika-annecy.com
Printed in Malta
The research leading to these results has received funding from the European
Community’s Seventh Framework Programme [FP7/2007-2013] under grant agreement
n° 222994 with the overall aim to improve the access to opioid medication in Europe.
Supported in part by Foundation Open Society Institute (Zug), the Ministry of Health, Welfare and Sport,
The Netherlands, the Mission interministérielle de la lutte contre la drogue et la toxicomanie, Government of
France (French translation), and the International Association for the Study of Pain.
This document was prepared as part of the Project Access to Opioid
Medications in Europe (ATOME)
Core scientific group / work package leaders: Lukas Radbruch, University of
Bonn / Malteser Krankenhaus Bonn/Rhein-Sieg, Germany; Willem Scholten, World
Health Organization; Sheila Payne, Lancaster University, United Kingdom; Asta Minkeviciene, Eurasian Harm Reduction
Association, Lithuania; Daniela Mosoiu, Hospice Casa Sperantei, Romania; Paula Frusinoiu, National Anti-Drug Agency,
Romania; David Praill, Help the Hospices, United Kingdom; Rick Lines, International Harm Reduction Association,
United Kingdom; Marie-Hélène Schutjens, Utrecht University, the Netherlands; Lukas Radbruch, European Association
for Palliative Care, Italy. Academic Advisory Board: Snezana Bosnjak, Institute for Oncology & Radiology, Serbia; David
Clark, University of Glasgow, United Kingdom; Ambros Uchtenhagen, Institut für Sucht- und Gesundheitsforschung
Zürich, Switzerland; John Lisman, Lisman Legal Life Sciences, the Netherlands; Stein Kaasa, The Norwegian University
of Science and Technology (NTNU), Norway; Per Sjøgren, Rigshospitalet, Copenhagen, Denmark. Project management:
Lukas Radbruch (project coordinator); Saskia Jünger (project executive officer); Willem Scholten (scientific
coordinator); Sheila Payne.
Website: www.atome-project.eu
Ensuring Balance in National Policies on Controlled Substances iii
TABLE OF CONTENTS
PREFACE. ................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
FOREWORD.................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 3
EXECUTIVE SUMMARY..................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
GLOSSARY .................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 6
INTRODUCTION TO THE GUIDELINES.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Purpose, target and scope.............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 10
Background.............................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 11
A dual obligation, a quadruple imperative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Indispensability of controlled medicines in contemporary medical practice. . . . . . . . . . . . . . . . . . . . . . . . . 13
Safety of controlled medicines.......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Current availability........................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 15
Impediments to availability, accessibility and affordability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Why and how to work with this document?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 16
GUIDELINES FOR ENSURING BALANCE IN NATIONAL POLICIES ON CONTROLLED
SUBSTANCES................................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 19
Content of drug control legislation and policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Authorities and their role in the system.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Policy planning for availability and accessibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Healthcare professionals................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Estimates and statistics.................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Procurement.............................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 34
Other...................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
COUNTRY ASSESSMENT CHECKLIST.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 39
ACKNOWLEDGEMENTS................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
DECLARATIONS OF INTEREST OF THE GUIDELINES DEVELOPMENT GROUP MEMBERS. . . . .. . 65
ANNEX 1. Controlled medicines also listed as WHO Essential Medicines or
WHO Essential Medicines for Children .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
ANNEX 2. Selected WHO treatment guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
ANNEX 3. Contents of the CD-ROM Ensuring balance in
national policies on controlled substances.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 77
Ensuring Balance in National Policies on Controlled Substances V
PREFACE
The international drug control treaties came into being to prevent the abuse of substances that can induce
dependence. The universal adoption of the treaties and their implementation continue to be highly effective
in preventing the diversion of drugs from licit to illicit markets in international trade and in protecting
society from the consequences of dependence. However, equal emphasis has not been placed on the other
fundamental objective of the treaties of ensuring that controlled substances are available for medical and
scientific purposes. As a result, the health benefits that can be derived from medicines containing controlled
substances remain inaccessible to the large majority of people around the world.
The majority of substances controlled under the international drug control treaties, notably narcotic
drugs and psychotropic substances, have a variety of medical uses. Opioid analgesics, such as codeine and
morphine, and antiepileptics, such as lorazepam and phenobarbital, are considered as essential medicines
by the World Health Organization. There is broad consensus that opioid analgesics are indispensable for the
treatment of moderate to severe pain and some, like methadone and buprenorphine, are increasingly used
for the treatment of drug dependence. The widespread recognition of the therapeutic value of controlled
substances has led in recent years to a substantial increase in their consumption. However, this increase
has occurred predominantly in developed countries. In contrast, the availability of controlled substances
has remained very low in most developing countries and is far from adequate to meet the medical needs
of their populations. Unless remedial measures are implemented, the gap in the availability of controlled
substances, namely opioid analgesics, will widen as the number of patients diagnosed with cancer and AIDS
in developing countries rises.
There are many reasons to account for the inadequate availability of controlled substances for medical
purposes. Some relate to the economic and social development of a country and affect the supply of
medicines in general. Others are specific to controlled substances and operate within the specific regulatory
system that exists in some countries for the manufacture, prescription and distribution of such substances.
In some countries, laws and regulations intended to prevent the misuse of controlled substances are overly
restrictive and impede patient access to medical treatment with such substances. Such situations can arise
when insufficient attention is paid to the impact of regulations on the supply of controlled substances for
medical purposes. Yet preventing the abuse of controlled substances and ensuring their availability for licit
uses are complementary, and not mutually exclusive, objectives of the international drug control treaties.
An effective drug control regime that complies with the spirit of the drug control treaties should therefore
strike the right balance between the considerations given to these two aims.
Undue regulatory restrictions often have their origins in poor understanding among policy makers about
controlled substances and their therapeutic value. Moreover, in many countries, inadequate knowledge
and fear of dependence are key reasons behind the unwillingness of health professionals to prescribe
controlled substances. To address these issues, policy makers need to go a step further than relaxing
regulatory restrictions to availability: they should devise and implement enabling policies that promote
widespread understanding about the therapeutic usefulness of controlled substances and their rational
use. Health professionals should be trained in prescribing and administering controlled substances.
Patients should be informed about the benefits and risks of using controlled substances. Drug control
and law enforcement personnel should be sensitized to their medical and scientific necessity. Promoting
dialogue among all these sectors is also essential to foster understanding and dispel misconceptions about
the medical use of controlled substances. Furthermore, it is by integrating the concerns of all sectors that
influence the use of controlled substances that policies can achieve the optimal balance between ensuring
access and preventing abuse.
Ensuring Balance in National Policies on Controlled Substances 1
Ensuring that controlled medicines reach those patients who need them most is a multifaceted challenge.
As such, it demands a response that is applied on many fronts and that requires the involvement of
and cooperation among many sectors of Government and society. This response should be rooted in the
recognition that controlled substances are indispensable for medical and scientific purposes. This recognition
means that ensuring access to controlled substances should be given due importance on the public health
agenda of countries. This recognition should also be at the source of the strong and sustained support that
all Governments must provide to the complex task of removing impediments to the availability of controlled
medicines and promoting their rational use.
Ensuring the adequate availability of controlled substances for medical and scientific purposes is one of
the objectives of the international drug control treaties that has yet to be universally achieved. As the
guardian of the international drug control treaties, the International Narcotics Control Board (INCB) has
often called upon Governments to give to this treaty objective the attention that it deserves in their drug
control policies. It is to assist Governments in this task that WHO, with the support of INCB, developed the
first version of the present guidelines ten years ago. Today, controlled substances continue to be important
for the relief from pain and suffering and have been recognised to be essential for treating some of the most
debilitating diseases and conditions that afflict our societies. It is therefore more than ever an imperative to
achieve a balance in controlled substances policies so that these work to protect societies from the misuse of
controlled substances without depriving them from their immense medical and scientific benefits.
Hamid Ghodse
President
International Narcotics Control Board
2
FOREWORD
These new World Health Organization (WHO) policy guidelines Ensuring balance in national policies on
controlled substances: guidance for availability and accessibility of controlled medicines build on a previous
set of guidelines, Achieving balance in national opioids control policy: guidelines for assessment, published
in 2000.
The 2000 document primarily addressed the need to address pain in cancer patients. However, WHO
estimates that every year 5.5 million terminal cancer patients still suffer moderate to severe pain that is not
managed at all. There is therefore a continued need for guidance in this area.
Cancer, however, is not the only cause of pain. WHO estimates that tens of millions of people experience
unrelieved pain from different diseases and conditions other than cancer, and therefore require access to
medicines (many of which are controlled) to relieve pain.
And controlled medicines are not only used to relieve pain. Better access to different controlled medicines
could prevent for instance 130 000 new HIV infections among injecting drug users, and around 75 000 cases
of maternal death.
The new guidelines cover a wider range of medicines and signal aspects that were previously not covered, but
that should be considered while working on improving access: human rights, gender and the public health
perspective.
The challenge now is to implement them. WHO commits to helping countries use the guidelines, assisting
them in carrying out assessments of legislation and policies and assisting in strategies to overcome the
current barriers for access.
Dr Carissa F. Etienne
Assistant Director-General
Health Systems and Services
World Health Organization
Ensuring Balance in National Policies on Controlled Substances 3EXECUTIVE SUMMARY
Ensuring balance in national policies on controlled substances: guidance for availability and accessibility of
controlled medicines provides guidance on policies and legislation with regards to availability, accessibility,
affordability and control of medicines made from substances regulated under the international drug control
conventions, herein referred to as “controlled medicines”. Their scope encompasses “all controlled medicines”,
but with a specific focus on essential medicines. Controlled medicines play an important role in several areas
of medicine, including pain treatment, treatment of opioid dependence, emergency obstetrics, psychiatry and
neurology.
The availability, accessibility and affordability of controlled medicines are important issues for all countries,
but problematic for most of them. The World Health Organization (WHO) promotes governments, civil society
and other interested individuals to strive for the maximum public health outcome of policies related to
these medicines. WHO considers the public health outcome to be at its maximum (or “balanced”) when the
optimum is reached between maximizing access for rational medical use and minimizing substance abuse.
Policy-makers, academia, civil society and other individuals whose area of work or interest is drug control
or public health may potentially work with these guidelines in order to ensure that better use is made of
controlled medicines and that more patients benefit from the advantages that their rational use can offer.
All countries have a dual obligation with regard to these medicines based on legal, political, public health
and moral grounds. The dual obligation is to ensure that these substances are available for medical purposes
and to protect populations against abuse and dependence. Countries should aim at a policy that ultimately
achieves both objectives; in other words, a “balanced policy”.
The core legal basis for this obligation can be found in the international drug control conventions. Legal
principles supporting national responsibility to ensure availability for medicinal purposes is also expressed in
several legal instruments elaborating the international right to health. The political grounds can be found
in various Millennium Development Goals, which cannot be achieved without controlled medicines. From
the public health perspective, there are many societal benefits, including cost savings and reduction of
transmission of infectious disease. Obviously, there is a moral obligation on governments to prevent people
from suffering or dying if this is in any way preventable.
However, WHO estimates that every year tens of millions of people suffer disease, moderate to severe pain
and ultimately death due to not having access to controlled medicines, including:
• 1 million end-stage HIV/AIDS patients;
• 5.5 million terminal cancer patients;
• 0.8 million patients suffering injuries caused by accidents or violence;
• Patients with chronic illnesses;
• Patients recovering from surgery;
• Women in labour (110 million births each year);
• Paediatric patients;
• 130 000 preventable new HIV infections and an unknown number of other blood-borne infections;
• 75 000 women who die during childbirth.
After 1986, the total global consumption of morphine increased significantly, but the increase only occurred
in a limited number of industrialized countries. Approximately 80% of the world’s population does not
have access to morphine for pain relief. For the pharmacological treatment of dependence syndrome, only
70 countries have services that are operational, while globally only 8% of injecting drug users receive this
therapy.
4Controlled medicines may be unavailable, inaccessible or unaffordable for a variety of reasons, including:
• legislation and policy issues;
• lack of knowledge and societal attitude;
• economic aspects.
Governments should therefore work continuously on all of these aspects in order to make controlled
medicines available, accessible and affordable.
This document provides 21 guidelines for working on the improvement of availability, accessibility and
affordability of controlled medicines from a policy perspective. They relate to seven aspects of policy and
legislation:
• content of drug control legislation and policy (Guidelines 1 and 2);
• authorities and their role in the system (Guidelines 3 to 6);
• policy planning for availability and accessibility (Guidelines 7 to 10);
• healthcare professionals (Guidelines 11 to 14);
• estimates and statistics (Guidelines 15 to 17);
• procurement (Guidelines 18 to 20);
• other (Guideline 21).
For each guideline, an explanation is provided, as well as the legal background and/or justification for the
guideline. A Country Assessment Checklist is also provided that enables users of the guidelines to check the
extent to which they are adhered to in a particular country.
The guidelines may be used by governments, health professionals and others as a national policy and
legislation evaluation tool, by providing a basis for formulating new policies and legislation or improving
existing policies and legislation; they may also be used as an educational tool to inform interested parties
about the relationship between national drug control policy and legislation and the availability and
accessibility of controlled medicines. Countries who wish to formulate new policy in this area, or improve
existing policies and legislation may also want to work with WHO’s Access to Controlled Medications
Programme (ACMP). The ACMP was jointly developed by the International Narcotics Control Board (INCB)
and WHO, and is operated by WHO.
This publication also includes several annexes and a CD-ROM that provide additional documentation.
The use of these guidelines and the Country Assessment Checklist may enable governments to systematically
identify and assess policy barriers, and gradually progress towards a situation where controlled medicines are
both readily available and accessible.
With the publication of this document, the previous guidelines Achieving balance in national opioids control
policy: guidelines for assessment (2000) are withdrawn.
Ensuring Balance in National Policies on Controlled Substances 5GLOSSARY a
Abuse is defined by the WHO Expert Committee on Drug Dependence as “persistent or sporadic excessive
drug use inconsistent with or unrelated to acceptable medical practice” (1). Abuse of a substance is a term
in wide use but of varying meaning. The term “abuse” is sometimes used disapprovingly to refer to any drug
use at all, particularly of illicit drugs. Because of its ambiguity, “abuse” is not used in ICD-10, except in the
case of non-dependence-producing substances; harmful use and hazardous use are the equivalent terms
in WHO usage, although they usually relate only to effects on health and not to social consequences (2).
The international drug conventions use the word “abuse” and not “misuse” or “harmful and hazardous use”;
therefore, these guidelines use this word frequently, in particular when in relation to the conventions or their
objectives.
Accessibility is the degree to which a medicine is obtainable for those who need it at the moment of need
with the least possible regulatory, social or psychological barriers.
Affordability is the degree to which a medicine is obtainable for those who need it at the moment of need
at a cost that does not expose them to the risk of serious negative consequences such as not being able to
satisfy other basic human needs.
Agonist is a substance that binds to a receptor of a cell and triggers a response by that cell. Agonists often
mimic the action of a naturally occurring substance.
Analgesic is a medicine that reduces pain.
Antagonist is a substance that blocks the action of an agonist.
Availability is the degree to which a medicine is present at distribution points in a defined area for the
population living in that area at the moment of need.
Consumption statistics have to be reported by governments to the International Narcotics Control Board
(INCB) annually and represent the amounts of narcotic drugs that were distributed in the country to the
retail level, i.e. to hospitals, pharmacies and practitioners.
Controlled medicines are medicines containing controlled substances.
Controlled substances are the substances listed in the international drug control conventions.
Convention is a formal agreement between States. The generic term “convention” is thus synonymous with
the generic term “treaty”. Conventions are normally open for participation by the international community
as a whole, or by a large number of States. Usually the instruments negotiated under the auspices of an
international organization are entitled conventions (3, 4).
Defined Daily Dose (DDD) is the assumed average maintenance dose per day for a medicine used on its
main indication in adults (5).
Dependence is defined by the WHO Expert Committee on Drug Dependence as “A cluster of physiological,
behavioural and cognitive phenomena of variable intensity, in which the use of a psychoactive drug (or
a References to this guidelines document can be found on the CD-ROM and on the internet at www.who.int/entity/medicines/areas/
quality_safety/ReferencesEnsBal.pdf
6drugs) takes on a high priority. The necessary descriptive characteristics are preoccupation with a desire to
obtain and take the drug and persistent drug-seeking behavior. Determinants and problematic consequences
of drug dependence may be biological, psychological or social, and usually interact” (6). Dependence is
clearly established to be a disorder. WHO’s International classification of diseases, 10th Edition (ICD-10) (7)
requires for Dependence syndrome that three or more of the following six characteristic features have been
experienced or exhibited:
(a) a strong desire or sense of compulsion to take the substance;
(b) difficulties in controlling substance-taking behaviour in terms of its onset, termination, or levels
of use;
(c) a physiological withdrawal state when substance use has ceased or been reduced, as evidenced
by: the characteristic withdrawal syndrome for the substance; or use of the same (or a closely
related) substance with the intention of relieving or avoiding withdrawal symptoms;
(d) evidence of tolerance, such that increased doses of the psychoactive substance are required in
order to achieve effects originally produced by lower doses;
(e) progressive neglect of alternative pleasures or interests because of psychoactive substance
use, increased amount of time necessary to obtain or take the substance or to recover from its
effects;
(f) persisting with substance use despite clear evidence of overtly harmful consequences, such as
harm to the liver through excessive drinking, depressive mood states consequent to periods of
heavy substance use, or drug-related impairment of cognitive functioning; efforts should be
made to determine that the user was actually, or could be expected to be, aware of the nature
and extent of the harm.
The Expert Committee on Drug Dependence (ECDD) concluded that “there were no substantial inconsistencies
between the definitions of dependence by the ECDD and the definition of dependence syndrome by the ICD-
10” (6).
Diversion refers to the movement of controlled drugs from licit to illicit distribution channels or to illicit use.
Essential medicines (for children) are those medicines that are listed on the WHO Model List of Essential
Medicines or the WHO Model List of Essential Medicines for Children. Both model lists present a list of
minimum medicine needs for a basic healthcare system, listing the most efficacious, safe and cost-effective
medicines for priority conditions. Annex 1 provides a list of controlled medicines also included on these Lists.
Estimates of the requirements for controlled substances for legitimate purposes have to be submitted to
INCB by the national competent authority. For narcotic drugs and for certain precursor chemicals, estimates
have to be submitted to INCB annually and for psychotropic substances, simplified estimates (known as
assessments) have to be submitted at least every three years.
International drug control conventions are the Single Convention on Narcotic Drugs of 1961 as amended
by the 1972 Protocol, the Convention on Psychotropic Substances of 1971, and the United Nations
Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.
Law refers to a set of rules on a specific topic enacted by the legislative body at the national, state or local
level and having binding legal force.
Legislation refers to all rules having binding legal force at the national, state or local level.
Maintenance therapy (or opioid substitution therapy) with long-acting opioid agonists for the treatment
of opioid dependence involves relatively stable doses of the agonists (usually methadone or buprenorphine)
prescribed over prolonged periods of time (usually more than six months), which allows stabilization of brain
functions and prevention of craving and withdrawal (8).
Ensuring Balance in National Policies on Controlled Substances 7Misuse (of a controlled substance) for the purposes of these guidelines, is defined as the non-medical and
non-scientific use of substances controlled under the international drug control treaties or under national law.
Narcotic drugs is a legal term that refers to all those substances listed in the Single Convention.
National authority, in these guidelines, refers to any government institution involved with the issues
discussed in this document. The term applies not just to national government institutions but may equally
apply to other relevant institutions in the national territory involved with these issues, such as federal, state
or provincial institutions.
National competent authority, in these guidelines, refers to any government agency responsible under
its national law for the control or regulation of a particular aspect of the country’s controlled substances
legislation, in particular to issue certificates and authorizations for the import and export of narcotic drugs
and psychotropic substances (9).
Opioid means literally “opium-like substance”. It can be used in different contexts with different but
overlapping meanings:
1. Botanical: chemical substances belonging to the class of alkaloids produced by the poppy plant (Papaver
somniferum L.). They can also be called natural opioids. Some of them (e.g. morphine and codeine) have
analgesic properties (“pain killers”); others do not.
2. Chemical: chemical substances having similar structural formulas as morphine, codeine and other natural
opioids (the benzylisoquinoline structure). They may be natural or synthetic. An example of a (semi-)synthetic
opioid is buprenorphine.
3. Pharmacological: chemical substances having similar pharmacological activity as morphine and codeine,
i.e. analgesic properties. They can stem from the poppy plant, be synthetic or even made by the body itself
(endorphins), and they may be structurally related to morphine or not. An example of a synthetic opioid not
structurally related to morphine is methadone.
Overly restrictive law or regulation: In these guidelines, the term “overly restrictive law or regulation”
refers to drug regulatory provisions that either:
a) do not materially contribute to the prevention of misuse of the controlled medicines but do create an
impediment to their availability and accessibility; or
b) have the potential to prevent the misuse of controlled medicines but disproportionately impede their
availability and accessibility.
Whether a drug regulatory provision disproportionately impedes availability and accessibility of controlled
medicines must be determined in each individual case and will depend on context, the extent of its
contribution to preventing the misuse of the medicines, the extent to which it impedes the availability and
accessibility of controlled medicines, and the availability of other control measures that could provide a
similar prevention but interfere less with the availability and accessibility of the medicine.
Party or State Party to a treaty is a country that has ratified or acceded to that particular treaty, and is
therefore legally bound by the provisions in the instrument (3).
Preamble is an introductory statement (e.g. to a convention) (10).
Psychotropic substances is a legal term that refers to all those substances listed in the Convention on
Psychotropic Substances.
Rational (medical) use, for the purposes of these guidelines, is defined as the appropriate use of a medicine
by both health professionals and consumers in their respective roles. Rational medical use aims at meeting
the clinical needs of the individual patient by prescribing, dispensing, and administering effective medicines
for the medical condition of the patient, at the adequate dose, within the required time schedule and for the
8required amount of time to treat or cure the patient’s medical condition; it should also enable the patient to
adhere to such treatment.
Regulation refers to a set of rules on a specific topic with binding legal force at the national, state or local
level and enacted by an administrative body to which the authority to issue such rules has been delegated by
the national, state or local legislative body.
Single Convention refers in this publication to the Single Convention on Narcotic Drugs, 1961, as amended
by the 1972 Protocol Amending the Single Convention on Narcotic Drugs, 1961 (11).
Tolerance refers to a reduction in the sensitivity to a pharmacological agent following repeated
administration, in which increased doses are required to produce the same magnitude of effect.
Withdrawal syndrome is the occurrence of a complex (syndrome) of uncomfortable symptoms or
physiological changes caused by an abrupt discontinuation or a dosage decrease after repeated
administration of a pharmacological agent. Withdrawal syndrome can also be caused by the administration
of an antagonist.
Ensuring Balance in National Policies on Controlled Substances 9INTRODUCTION TO THE
GUIDELINES
Purpose, target and scope
The purpose of these guidelines is to provide authoritative guidance on policies and legislation with regards
to availability, accessibility, affordability and control of medicines made from substances that are controlled
under the international drug control conventions (11-13).b In this document, these medicines will be referred
to as “controlled medicines”.
The availability, accessibility and affordability of controlled medicines are important issues for all countries, but
problematic for most of them. The World Health Organization (WHO) encourages governments, civil society
and other interested individuals to strive for the maximum public health outcome of policies related to these
medicines. WHO considers the public health outcome to be at its maximum (or “balanced”) when the optimum
is reached between maximizing access for rational medical use and minimizing hazardous or harmful use.
It is hoped that these guidelines, by identifying and overcoming the regulatory and policy barriers to the
rational use of controlled medicines, will enable governments to achieve better treatment of those patients
that require them.
The guidelines’ target audience (those groups and individuals whom it is envisaged will be encouraged to
utilize this document) is:
• policy-makers, regulators (in government, administrative departments, national competent
authorities) and politicians;
• academia and civil society;
• healthcare professionals and their organizations;
• individuals (including patients and their families) and organizations whose area of work or interest is
drug control or public health.
The scope of these guidelines is “all controlled medicines”. These are medicines made from substances controlled
internationally under the Single Convention on Narcotic Drugs (further called “Single Convention”) and
under the Convention on Psychotropic Substances. It also includes medicines made from precursors regulated
under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
Furthermore, they could also be other substances controlled under national drug laws and regulations.
The guidelines pay special attention to those medicines that are also listed on the WHO Model List of
Essential Medicines and on the WHO Model List of Essential Medicines for Children,c because these medicines
are essential for health and health care. In addition, governments should ensure balance in policies and
legislation with regard to other controlled medicines that are not listed as “essential medicines”.
b Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol; Convention on Psychotropic Substances, 1971;
United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.
c See Annex 1.
10Background
Controlled medicines play an important role in several medical areas. Opioids are used to treat pain (opioid
analgesia), and to treat opioid dependence (long-acting opioid agonist therapy). Other controlled medicines are
essential in emergency obstetrics (ergometrine, ephedrine) or used as anxiolytics and hypnotics (benzodiazepines)
or as anti-epileptics (phenobarbital and benzodiazepines).
There are a number of issues related to balanced policies and legislation that are covered by other documents.
For example, guidance for actual treatment is covered by a number of WHO treatment guidelines that have
been or will be developed with involvement of a group of international experts through a transparent evidence-
based process that aims to ensure their universal applicability. There are WHO treatment guidelines on opioid
dependence, cancer pain (including cancer pain in children), emergency obstetrics and HIV/AIDS. Treatment
guidelines relevant to this document are listed in Annex 2.
There are also a number of documents addressing practical aspects for implementing the recommendations
from this guidelines document, such as the UNODC publication A ‘step-by-step’ algorithm for the procurement
of controlled substances for substitution treatment, (practical information on importation of opioids) (14).
Furthermore, Guidelines for the international provision of controlled medicines for emergency medical care
may be applied to disaster relief settings (15). Currently, WHO and INCB are jointly developing guidelines for
estimating requirements for controlled substances.
The central principle of “balance”
The central principle of “balance” represents a dual obligation of governments to establish a system of control
that ensures the adequate availability of controlled substances for medical and scientific purposes, while
simultaneously preventing abuse, diversion and trafficking. Many controlled medicines are essential medicines
and are absolutely necessary for the relief of pain, treatment of illness and the prevention of premature death.
To ensure the rational use of these medicines, governments should both enable and empower healthcare
professionals to prescribe, dispense and administer them according to the individual medical needs of
patients, ensuring that a sufficient supply is available to meet those needs. While misuse of controlled
substances poses a risk to society, the system of control is not intended to be a barrier to their availability for
medical and scientific purposes, nor interfere in their legitimate medical use for patient care (16).
A dual obligation, a quadruple imperative
Countries have a dual obligation with regard to these medicines based on a quadruple imperative, which is based
on legal, political, public health and moral grounds. They must ensure that these substances are available for
medical purposes and they must protect their populations against abuse and dependence. Indeed, here lies the
challenge for both public-health and drug-control authorities. WHO promotes policies that simultaneously strive
for minimizing substance abuse and maximizing access for rational medical use. The combination that leads
to the maximum public health outcome is the optimum between these two elements, and a policy leading to
this optimum can be called a “balanced policy” (See box above, The central principle of “balance”). WHO’s work
towards balanced policies is supported by the INCB and the Commission on Narcotic Drugs (CND) in its Resolution
53/4 (in paragraph 10 and also in paragraphs 4, 6 and 9) (16, 17).
Moreover, in 2008, the United Nations’ Special Rapporteur on the prevention of torture and cruel, inhuman, or
degrading treatment or punishment, and the Special Rapporteur on the right of everyone to the enjoyment of
the highest attainable standard of physical and mental health, jointly wrote a letter to the CND on human rights
aspects of drug control, in which they requested that “national drug control laws recognize the indispensible
nature of narcotic and psychotropic drugs for the relief of pain and suffering, and guarantee adequate availability
of those medicines for legitimate medical uses, including opioid analgesics and opioids for substance dependence
programmes” (18).
Ensuring Balance in National Policies on Controlled Substances 11Legal imperative
The obligation to make controlled medicines available for medical purposes finds its legal basis in the international
drug control conventions, which state that “the medical use of narcotic drugs continues to be indispensable for
the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic
drugs for such purposes” (11).d Human rights principles supporting the duty to ensure adequate availability of
controlled medicines for medicinal purposes are also contained in international legal instruments expressing the
international right to health. A key instrument in this regard is the WHO Constitution, the first international legal
instrument expressing the right to health. In the WHO Constitution, the right to health is broadly formulated as
follows: “The States Parties to this Constitution declare, in conformity with the Charter of the United Nations,
that the following principles are basic to the happiness, harmonious relations and security of all peoples: Health
is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.
The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human
being without distinction of race, religion, political belief, economic or social condition.” (19).
Almost all countries worldwide are party to the international drug control conventions and have thus legally
committed their governments to making controlled substances available for medical purposes. In addition, most
countries are party to the WHO Constitution and/or the International Covenant on Economic, Social and Cultural
Rights (20), both of which recognize the right to health. For specific controlled medicines, such as those used
in obstetric emergencies, other human rights instruments may be applicable, including the right to life and
provisions specifically related to the rights of women to health (21, 22).
Political imperative
In September 2000, the United Nations adopted the United Nations Millennium Declaration (23) urging their
nations to reduce extreme poverty and setting out a series of targets with a recommended completion date of
2015. These have become known as the Millennium Development Goals. The eight Millennium Development
Goals (MDGs) form a blueprint that has been agreed upon by all of the world’s countries and all leading
development institutions.
Several MDGs affect essential medicines either directly or indirectly, including controlled medicines that are also
listed as essential medicines. In particular, MDGs include:
• “To encourage the pharmaceutical industry to make essential drugs more widely available and affordable
for all who need them in developing countries” (MDG 8e);
• “...To have reduced maternal mortality by three quarters, and under-five child mortality by two thirds, of
their current rates.” (MDG 5a);
• “...To have, by then, halted, and begun to reverse, the spread of HIV/AIDS, the scourge of malaria and
other major diseases that afflict humanity.” (MDG 6a).
In the MDGs, countries also agreed to “spare no effort to ... strengthen the rule of law, as well as respect for
all internationally recognized human rights” and “[t]o strive for the full protection and promotion in all our
countries of civil, political, economic, social and cultural rights for all.”
Public health imperative
Drug control should not be approached as an objective in itself, but as a tool to optimize public health.
One focus should be the prevention of abuse and dependence; the other to avoid collateral harm. The
outcomes should be judged both by the harms from abuse it prevents and the harm it causes through, for
example, lack of access.
d This wording is from the Single Convention on Narcotic Drugs; the Convention on Psychotropic Substances contains similar
wording for psychotropic substances.
12Untreated pain may cause losses to society in the form of incapacity to work, caregivers becoming unproductive
in society due to their caring role, and pain patients needing further attention if they do not receive adequate
pain management. Treatment of dependence syndrome may re-socialize people who previously were incapable of
work, and may serve to reduce petty crime and the risk of harmful behaviour by the individual; it may also reduce
the transmission of infectious disease through unsafe injection. Programmes that provide long-acting opioid
agonist treatment (or “substitution therapy”)e are cost-effective for a country (24).
Treatment of neurological and psychiatric disorders, including epilepsy, will be more effective if the medicines
needed for treatment are readily accessible. For emergency obstetric care, reducing the rate of maternal mortality
is an important target which cannot be achieved without making the appropriate medicines available.
Moral imperative
Aside from a legal and a political obligation and from public health considerations, a moral imperative also exists
to prevent suffering by making controlled medicines available and accessible; this is particularly true as suffering
can be prevented at a relatively low cost and without too much effort.
Without any efforts for change, the current situation will continue, with every year tens of millions of people
suffering from disease, moderate to severe pain or ultimately death (25). These include:
• 1 million end-stage HIV/AIDS patients;
• 5.5 million terminal cancer patients;
• 0.8 million patients suffering injuries caused by accidents and violence;
• patients with chronic illnesses;
• patients recovering from surgery;
• women in labour (110 million births each year);
• paediatric patients;
• 130 000 preventable new HIV infections and an unknown number of other blood-borne infections;
• 75 000 women who die during childbirth.
The consequences of a lack of availability of controlled medicines are severe and the numbers of patients afflicted
are at least the same in magnitude as those afflicted by conditions that are recognized as major contributors to
the world’s burden of disease; in particular HIV, malaria and tuberculosis.f
Indispensability of controlled medicines in contemporary medical practice
Analgesia
Pain is prevalent in almost all medical specialties, including in general practice, palliative care, oncology, internal
medicine, haematology and surgery. Patients who are affected include people who have cancer, HIV, sickle-cell
disease, or those who have had surgery or accidents.
Cancer patients may need pain relief at every stage of the disease. More than two thirds of patients with
advanced cancer and about half of all patients with advanced HIV/AIDS will experience moderate to severe pain
(25, 29, 30). In obstetrics, women may need pain relief during labour, surgery and post-surgery.
e The wording “substitution therapy” is misleading because it is not just replacing illicit drugs by officially approved drugs; there
is evidence now that hormone levels are normalized and because of the slow onset of the medicines used, there is no immediate
awarding sensation or “kick”. Therefore, the terminology “long-acting opioid agonist therapy” or “opioid agonist therapy” is preferred.
f HIV: incidence: 2.7 million/yr, prevalence: 33.4 million/yr, mortality: 2.0 million/yr (2008) (26)
Malaria: incidence: 243 million/yr, mortality: 863 000/yr (2008) (27)
Tuberculosis: incidence: 9.4 million/yr, prevalence: 11.1 million/yr, mortality: 1.3 million (2008) (28)
Ensuring Balance in National Policies on Controlled Substances 13For all of these patients, pain relief should be part of their overall treatment. Oral opioids are key components
for the treatment of moderate to severe pain and several are regarded as essential medicines (25, 31, 32).
Paracetamol (acetaminophen), acetylsalicylic acid, non-steroidal anti-inflammatory medicines (NSAIMs) when
used alone and weak acting opioids (tramadol, codeine) are usually not effective in the case of moderate to
severe pain. NSAIMs can have serious side-effects and should be used with caution on a chronic basis (33, 34).
Despite a century of pharmaceutical chemistry, suitable alternatives to strong opioids for treatment of moderate
to severe pain have yet to be found.
Unrelieved pain can impair all aspects of a person’s life, impacting on emotional, physical and social functioning;
unrelieved severe pain can even result in a wish for death to occur (35).
Treatment of opioid dependence syndrome and prevention of HIV
Globally, there are an estimated 16 million people who inject illicit drugs (36). The number of people who are
dependent on opioids who do not inject is much higher. In 2008, UNODC estimated that globally, between 12.8
and 21.9 million people illicitly used opioids over the previous 12 months, with the prevalence ranging between
0.3% and 0.5% of the world’s population aged 15 - 64 (37). Of the new HIV infections in Eastern Europe and
Central Asia in 2005, 62% were due to injection drug use (38).
There is strong evidence for the efficacy of treatment of opioid dependence with long-acting opioid agonists
such as oral methadone and buprenorphine which effectively reduce and prevent injecting drug use and thus
contribute to containing hepatitis B and C and the HIV/AIDS epidemic. Treatment with long-acting opioid
agonists also reduces mortality from heroin overdose by 90% (39). Moreover, it allows patients with opioid
dependence to function more fully in society. Dependence is a disorder associated with neurobiological changes
in opioid peptides and other neuropeptides that can be stabilized with long-acting opioid therapy (40); legislation
should therefore focus on treatment, not punishment. However, it is estimated that, worldwide, only 8% of
injecting drug users have access to treatment for opioid dependence (41).
Other uses of essential controlled medicines
Opioids are also used in anaesthesia and, additionally, morphine is used for treating dyspnoea and anxiety
resulting from dyspnoea. Codeine and some other weak acting opioids are used to treat coughs and diarrhoea.
Ergometrine and ephedrine, two substances frequently diverted for the production of illicit drugs, play important
roles in emergency obstetrics and can prevent maternal death. Each year, half a million women die during
childbirth (42), about 120 000 of them from post-partum bleeding (43). Many of these lives could be saved if
medicines to stop the bleeding were more widely available.
Ketamine is an essential medicine, pivotal for anaesthesia. In rural areas of developing countries in particular,
ketamine is the only suitable and safe anaesthetic. Although not listed in the international drug treaties,
ketamine is now under national control in approximately 50 countries worldwide. In 2006, the CND called upon
governments “to consider controlling the use of ketamine by placing it on the list of substances controlled under
their national legislation, where the domestic situation so requires” (44, 45). Ketamine is still under review by
WHO’s Expert Committee on Drug Dependence (46). National control policies with regard to ketamine should be
balanced in order to ensure surgery is available to rural populations (47).
Other medicines are important for neurology and psychiatry, for example in the treatment of epilepsy, anxiety
and sleeplessness. In some countries, overconsumption of benzodiazepines as hypnotics and anxiolytics occurs.
When used as hypnotics and anxiolytics, they are indicated for use during a brief period in crisis situations only,
but are often prescribed for extended periods. On the other hand, controlled medicines for the treatment of
epilepsy, such as phenobarbital and benzodiazepines, may scarcely be available. In Africa, 80% of the population
affected by epilepsy has no access to essential antiepileptic medicines (48).
Finally, controlled substances are important for scientific purposes, e.g. for medical research (including clinical
trials), for research into dependence, and for use in forensic laboratories.
14Safety of controlled medicines
It should be recognized that controlled medicines when used rationally for medical purposes are safe medicines.
Opioid analgesics, if prescribed in accordance with established dosage regimens, are known to be safe and there
is no need to fear accidental death or dependence. A systematic review of research papers concludes that only
0.43% of patients with no previous history of substance abuse treated with opioid analgesics to relieve pain
abused their medication and only 0.05% developed dependence syndrome (49).
This may be explained by a postulated neurobiological mechanism (50).
Current availability
The total global consumption of opioids increased significantly after 1986, when WHO introduced the Analgesic
Ladder for cancer pain relief. However, the increase occurred in a limited number of mainly industrialized
countries that represent only a small part of the world’s population (51, 52). It is estimated that 80% of the
world’s population does not have access to morphine for pain relief (53).
Morphine: distribution of consumption, 2009
Japan (2,4%)
Other countries (78,6%)
0,8%
Percentage of
world population 6,2% Australia and
living in this country New Zealand (0,5%)
2,9%
United States (5,5%)
Canada (0,6%)
55,9%
6,2%
Percentage of
global morphine
consumption
consumed by
this country
Europe (12,4%)
28%
Source: INCB
Any statistics contain an inherent inaccuracy (usually from underreporting) and this will be equally true for
the statistics on controlled substances. However, the statistics on narcotic drugs and psychotropic substances
published by the INCB (53) can be considered as reliable, because the administrative systems provided for by the
Single Convention and the 1971 Convention obligate governments to report statistical data to the INCB, which
then investigates any inconsistencies.
For the treatment of opioid dependence syndrome, despite the fact that injecting drug use has been reported
from almost every country in the world, only 70 countries (out of 193) have services where long-acting opioid
agonist therapy is operational, and it is estimated that worldwide only 8% of injecting drug users receive this
therapy (compared to 61% in Western Europe, where it is a standard treatment option) (41).
Ensuring Balance in National Policies on Controlled Substances 15Impediments to availability, accessibility and affordability
It is almost a century since the first international drug control convention came into force (54), and the
drug control conventions that established the dual obligation of ensuring adequate availability of controlled
medications and of preventing their misuse have existed for almost 50 years. Yet the obligation to prevent abuse
of controlled substances has received far more attention than the obligation to ensure their adequate availability
for medical and scientific purposes, and this has resulted in countries adopting laws and regulations that
consistently and severely impede accessibility of controlled medicines.
The INCB and WHO have highlighted overly restrictive laws and regulations that impede the adequate availability
and medical use of opioids (31, 32, 51, 55 - 58). As far back as 1989 (55), the INCB drew attention to some
governments’ overreaction to the drug abuse problem when “the reaction of some legislators and administrators
to the fear of drug abuse developing or spreading has led to the enactment of laws and regulations that may, in
some cases, unduly impede the availability of opiates”. INCB also stated that “legislators sometimes enact laws
which not only deal with the illicit traffic itself, but also impinge on some aspects of licit trade and use, without
first having adequately assessed the impact of the new laws on such licit activity. Heightened concern with the
possibility of abuse may also lead to the adoption of overly restrictive regulations which have the practical effect
of reducing availability for licit purposes”.
In each guideline of this document, the type of measures that contribute or do not contribute to the prevention
of abuse and dependence and the type of measures that are an impediment to availability and accessibility for
rational medical use are explained. Many practical examples of barriers at various levels are provided, including:
• legislation and policy;
• knowledge and societal attitude;
• economic aspects, including affordability.
In order to improve access, governments should work continuously on all of these aspects in order to make
controlled medicines available, accessible and affordable.
Why and how to work with this document?
The imperative for evaluation of national drug control policies
For a quarter of a century, attention has been drawn to the fact that the level of consumption of controlled
medicines worldwide does not match the needs for health care. In some countries the consumption level has
improved over this period, but in most countries there has been little significant change.
In 2010, the INCB stated that “discrepancies in the consumption levels of opioid analgesics in different countries
continue to be very significant. Factors such as knowledge limitations and administrative barriers stricter than
the control measures required under the 1961 Convention affect the availability of opioid analgesics”. The
INCB requested “the Governments concerned to identify the impediments in their countries to access to and
adequate use” (52). Also, as INCB had done previously, CND and WHO have called on governments to evaluate
their healthcare systems and laws and regulations, and to identify and remove impediments to the availability of
controlled substances for medical needs (16, 31, 32, 51, 55 - 57).
Using the guidelines
The guidelines in the next chapter may be used by governments, health professionals and others. The guidelines
can be used as:
• a policy and legislation evaluation tool;
• a basis for formulating new policies and legislation or improving existing policies and legislation;
• an educational tool to inform interested parties about the relationship between national drug control
policy and legislation and the availability and accessibility of controlled medicines.
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